What is ketoconazole?

Ketoconazole is an antifungal medication that is used to treat certain infections caused by fungus.

ketoconazole should be used only when you cannot use other antifungal medications. Ketoconazole can cause serious harm to your liver that may result in liver transplant or cause death.

Ketoconazole is not for use in treating fungal infections of the fingernails or toenails. This medicine is also not for use in treating prostate cancer or Cushing syndrome.

Ketoconazole may also be used for purposes not listed in this medication guide.

Ketoconazole side effects

Get emergency medical help if you have signs of an allergic reaction (hives, fever, chest pain, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Ketoconazole may cause serious side effects. Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• unusual weakness or tiredness, dizziness, nausea, and vomiting; or
• liver problems–upper stomach pain, fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Common side effects of ketoconazole may include:

• nausea, diarrhea, stomach pain
• breast swelling;
• headache, dizziness; or
• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

ketoconazole should be used only when you cannot use other antifungal medications. Ketoconazole can cause serious harm to your liver that may result in liver transplant or cause death.

Call your doctor at once if you have any signs of liver damage, such as nausea, vomiting, stomach pain, fever, tiredness, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Ketoconazole can also cause a serious heart problem. Call your doctor right away if you have fast or pounding heartbeats, shortness of breath, and sudden dizziness.

Before taking this medicine

You should not use ketoconazole if you are allergic to it, or if you have liver disease.

Some medicines can cause unwanted or dangerous effects when used with ketoconazole. Your doctor may change your treatment plan if you also use:

• cisapride;
• colchicine;
• irinotecan;
• methadone;
• tolvaptan;
• antipsychotic medicine–pimozide, lurasidone;
• cholesterol medication–lovastatin, simvastatin, and others;
• ergot medicine–dihydroergotamine, ergotamine, ergonovine, methylergonovine;
• heart medication–disopyramide, dofetilide, dronedarone, eplerenone, felodipine, nisoldipine, quinidine, ranolazine; or
• a sedative–alprazolam, midazolam, or triazolam.

Tell your doctor if you have ever had:

• liver problems;
• long QT syndrome (in you or a family member); or
• problems with your adrenal gland.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

You should not breast-feed while using this medicine.

Do not give this medicine to a child without medical advice.

How should I take ketoconazole?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using ketoconazole.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may need to use ketoconazole for up to 6 months.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Ketoconazole will not treat a viral infection such as the flu or a common cold.

While using ketoconazole, you may need frequent blood tests to check your liver function.

Store at room temperature away from moisture, heat, and light.

Do not share this medicine with another person, even if they have the same symptoms you have.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking ketoconazole?

Do not drink alcohol. Dangerous side effects could occur.

Ketoconazole could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect ketoconazole?

Some medicines can make it harder for your body to absorb ketoconazole. If you take an antacid, take it 1 hour before or 2 hours after you take ketoconazole. Tell your doctor if you also take a stomach acid reducer, such as Nexium, Prevacid, Prilosec, Protonix, Zantac, and others.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Ketoconazole can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

What is ketoconazole topical?

Ketoconazole topical (for the skin) is an antifungal medicine used to treat infections such as athlete’s foot, jock itch, ringworm, and seborrhea (dry, flaking skin or dandruff).

Ketoconazole topical is also used to treat a fungal infection called pityriasis, which causes scaly discolored patches on the skin of the neck, chest, arms, or legs.

Ketoconazole topical may also be used for purposes not listed in this medication guide.

Ketoconazole topical side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Ketoconazole topical may cause serious side effects. Call your doctor at once if you have:

• burning, stinging, or severe irritation after using ketoconazole topical;
• redness, pain, or oozing of treated skin; or
• shortness of breath.

Common side effects of ketoconazole topical may include:

• thinning hair;
• changes in the color or texture of your hair;
• dry skin; or
• mild itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use ketoconazole topical if you are allergic to ketoconazole.

Ask a doctor or pharmacist if this medicine is safe to use if you have:

• asthma or a sulfite allergy;
• an allergic reaction to an antifungal medicine, such as clotrimazole, econazole, or miconazole.

Ask a doctor before using this medicine if you are pregnant.

You should not breast-feed while using ketoconazole topical.

Always follow directions on the medicine label about using this medicine on a child.

How should I apply ketoconazole topical?

Use exactly as directed on the label, or as prescribed by your doctor.

Using more of this medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects.

Do not take by mouth. Topical medicine is for use only on the skin. Do not use on open wounds or irritated skin. Rinse with water if this medicine gets in your eyes, nose, or mouth.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Wash your hands before and after using this medicine.

Clean and dry the skin before applying ketoconazole cream, foam, or gel.

This medicine may be flammable. Do not use near high heat or open flame, or while smoking. Avoid heat or smoking until the medicine has completely dried on your skin.

Ketoconazole shampoo is not for daily use. Allow at least 3 days to pass between uses.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication.

Call your doctor if your symptoms do not begin to improve after 2 to 4 weeks of treatment, or if your condition gets worse.

Store ketoconazole topical at room temperature. Protect from light and do not refrigerate or freeze.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

An overdose of ketoconazole topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

What should I avoid while using ketoconazole topical?

Do not get ketoconazole topical in your eyes. If contact does occur, rinse with water.

Avoid covering treated skin areas with tight-fitting, synthetic clothing (such as nylon or polyester) that doesn’t allow air to circulate to your skin. If you are treating your feet, wear clean cotton socks and sandals or shoes that allow for air circulation. Keep your feet as dry as possible.

You may need to avoid sunlight if you are treating pityriasis. Follow your doctor’s instructions.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

Avoid using other medications on the areas you treat with ketoconazole topical unless your doctor tells you to.